Phase II Study of TKI258 in Advanced Urothelial Carcinoma
- Registration Number
- NCT00790426
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis
- Patients who have archival tumor tissue available for FGFR3 mutational status screening
- Patients with progressive disease
- Patients with measurable disease by RECIST
- Patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting
- Age ≥ 18 years
- WHO Performance Status ≤ 2
- Patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests
- Patients with signed and witnessed informed consent form
- Patients with adequate organ function
- Patients with brain cancer
- Patients with other cancers except for certain skin, cervical & prostate cancers
- Patients who have not recovered from previous cancer treatment
- Patients who have severe and/or uncontrolled medical conditions which could affect participation in the study
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FGFR3 wild type TKI258 - FGFR3 mutant TKI258 -
- Primary Outcome Measures
Name Time Method Overall response rate 4 months
- Secondary Outcome Measures
Name Time Method Disease control rate 4 Months Progression free survival 4 Months overall survival 4 Months
Trial Locations
- Locations (9)
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
🇺🇸Los Angeles, California, United States
University Chicago Hospital CTKI258A2201
🇺🇸Chicago, Illinois, United States
Duke University Medical Center Dept.ofDukeUniversityMedCtr(2)
🇺🇸Durham, North Carolina, United States
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2)
🇺🇸New York, New York, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Dana Farber Cancer Institute Dana 1230
🇺🇸Boston, Massachusetts, United States
Nevada Cancer Institute Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Novartis Investigative Site
🇬🇧Southampton, United Kingdom
University of California San Diego - Moores Cancer Center UCSD
🇺🇸La Jolla, California, United States